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Product name
|
Pemetrexed Disodium 2.5hydrate
|
|
CAS NO.
|
357166-30-4
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|
Appearance
|
White or off-white crystalline powder, tasteless
|
|
Hygroscopicity
|
15%min
|
|
Specific rotation
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+10.0°~ +16.0°
|
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Identification
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Chemical test: Positive reaction
HPLC
|
|
Alkalinity
|
7.0-8.5
|
|
Clarification & color of solution
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The color should not thicker than second standard yellow solution
|
|
Heavy metals
|
0.001%max
|
|
Chloride
|
0.03%max
|
|
Moisture
|
8.5-10.0%
|
|
Related substances
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Single impurity: 0.10%max
Total impurities: 1.0%max
|
|
Optical isomer
|
0.5%max
|
|
Ethanol
|
0.5%max
|
|
Dichloromethane
|
0.06%max
|
|
Methanol
|
0.3%max
|
|
THF
|
0.072%max
|
|
Acetone
|
0.5%max
|
|
N,N-DMF
|
0.088%max
|
|
Assay (on dried basis)
|
98.5% min
|
>>Alphabetical order
